Trial in Patients With Relapsed Ovarian Cancer

NCT03267589 | Completed Phase 2 DMC

• 1 other identifier: ENGOT-OV30 / NSGO
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 5

Brief Summary

The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the standard of care (SoC).

Conditions

Ovarian Cancer

Keywords

immunotherapy; ovarian cancer; durvalumab; tremelilumab; MEDI 9447; MEDI 0562

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  Disease control rate (DCR) (CR+PR+SD)

  16 weeks

Secondary Outcomes (5)

• Progression-Free Survival (PFS) by RECIST v1.1

  10 months

• PFS by Immune-RECIST

  10 months

• Overall survival (OS)

  36 months

• Objective response rate

  10 months

• Duration of (Overall) Response (DoR)

  10 months

Study Arms (3)

Cohort A

EXPERIMENTAL

Intervention: MEDI9447 (CD73) + durvalumab

Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Cohort B

EXPERIMENTAL

Intervention: MEDI0562 (OX40) + durvalumab

Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Cohort C

EXPERIMENTAL

Intervention: MEDI0562 (OX40) + tremelimumab combination

Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Interventions

Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 DRUG

Three different combination are being tested. Each cohort has different combination

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. Patients must have received atleast one line of chemotherapy for platinum-sensitive disease. OR
• Platinum-resistant disease: defined as disease progression \< 6 months following the last administered dose of platinum-based therapy.
• Platinum-refractory disease: defined as lack of response or disease progression while receiving the most recent therapy.
• Histological confirmed ovarian, fallopian tube or peritoneal cancers.
• Histological types: high-grade serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
• Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not be the same lesion used for biopsy.
• Patients entering cohort A: Archival tumour tissue must be screened for CD73 and only CD73 positive patients (defined as \>10% of tumor cells positive) will enter this trial.
• Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol.
• Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
• Patients must give informed consent.
• Patients must be at least 18 years of age.
• ECOG performance status 0-1
• Serum albumin \>30g/l.
• Adequate organ function
• Life expectancy of at least 12 weeks.

You may not qualify if:

• Subjects using immunosuppressive medications within 14 days.
• Immunodeficiency or organ transplant
• Live vaccines within 28 days prior to the first dose.
• Major surgery within 28 days prior to the first dose.
• Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
• Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose.
• Concurrent treatment with an investigational agent or participation in another clinical trial.
• Previous malignant disease: patients are not eligible for the study if actively being treated of inva-sive cancer other than ovarian cancer. Patients with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study. Pa-tients with previous history of in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
• Active infection including tuberculosis
• History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months.
• History of clinically significant hemorrhage in the past 3 months.
• Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off steroids for 14 days.
• Significant cardiovascular disease's.
• Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).
• Known hypersensitivity to the trial drugs, or to their excipients.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• Gynecologic Cancer Intergroup (GCIG): collaborator
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator

Study Sites (5)

Rigshospitalet

København Ø, Region Sjælland, 2100, Denmark

Location

VejleSygehus

Vejle, Region Syddanmark, 7100, Denmark

Location

Tampere University Hospital

Tampere, Finland

Location

Haukeland University Hospital

Bergen, Haukeland, 5021, Norway

Location

The Norwegian Radium Hospital

Oslo, 0310, Norway

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Mansoor R Mirza, MD

  NSGO-CTU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 30, 2017
• Study Start: May 14, 2018
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From December 2023.

Locations

DK (2); FI (1); NO (2)